Different doses of ZED1227 vs. placebo in NAFLD

Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of ZED1227 capsules with placebo in the treatment of non-alcoholic fatty liver disease (NAFLD) with significant fibrosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002253-29-PL

Enrollment

160

Registered

2022-01-19

Start date

2022-03-01

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 25.0 Level: PT Classification code 10029530 Term: Non-alcoholic fatty liver System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Product Name: ZED1227 Pharmaceutical Form: Capsule, hard Other descriptive name: ZED1227 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Has provided signed informed consent - Is a male or female = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Has a history of significant alcohol consumption (an average of > 20 g/d in females and > 30 g/d in males) - Has a history or presence of any other significant concomitant liver diseases - Has diagnosed type 1 diabetes mellitus (T1DM) - Has presence of cirrhosis

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to evaluate the efficacy of three doses of ZED1227 versus (vs.) placebo for the treatment of patients with NAFLD with fibrosis;Secondary Objective: The secondary objective of this trial is to study the safety of ZED1227 for the treatment of patients with NAFLD with fibrosis;Primary end point(s): The primary efficacy variable is the relative change of serum levels of PRO C3 ;Timepoint(s) of evaluation of this end point: Between baseline and the EOT/withdrawal visit	—

Measure

Time frame

Main Objective: The primary objective of this trial is to evaluate the efficacy of three doses of ZED1227 versus (vs.) placebo for the treatment of patients with NAFLD with fibrosis;Secondary Objective: The secondary objective of this trial is to study the safety of ZED1227 for the treatment of patients with NAFLD with fibrosis;Primary end point(s): The primary efficacy variable is the relative change of serum levels of PRO C3 ;Timepoint(s) of evaluation of this end point: Between baseline and the EOT/withdrawal visit

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy variables include: •Change in the levels of the following non-invasive markers of fibrosis from baseline to selected interim visits and from baseline to the EOT/withdrawal visit: -Enhanced Liver Fibrosis [ELF] Score -Fibrosis-4 [FIB-4] Score -NAFLD Fibrosis Score [NFS] -AST to Platelet Ratio Index [APRI] -ADAPT Score -FIBC3 Score •Absolute and relative (%) change in the levels of the following liver parameters from baseline to each visit up to the EOT/withdrawal visit: -ALT -AST -?-glutamyltransferase (GGT). ;Timepoint(s) of evaluation of this end point: From baseline to each visit up to the EOT/withdrawal visit	—

Measure

Time frame

Secondary end point(s): The secondary efficacy variables include: •Change in the levels of the following non-invasive markers of fibrosis from baseline to selected interim visits and from baseline to the EOT/withdrawal visit: -Enhanced Liver Fibrosis [ELF] Score -Fibrosis-4 [FIB-4] Score -NAFLD Fibrosis Score [NFS] -AST to Platelet Ratio Index [APRI] -ADAPT Score -FIBC3 Score •Absolute and relative (%) change in the levels of the following liver parameters from baseline to each visit up to the EOT/withdrawal visit: -ALT -AST -?-glutamyltransferase (GGT). ;Timepoint(s) of evaluation of this end point: From baseline to each visit up to the EOT/withdrawal visit

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Countries

Germany, Poland, Spain

Contacts

Public ContactDept. of Clinical Research&Developm

Dr. Falk Pharma GmbH

judith.czarnecki@drfalkpharma.de0049761 1514 264

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026